Safety After Oral IntakePhase 1NCT07220889
Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
A Phase 1 study testing MDI-2517 800mg, MDI-2517 1600mg and MDI-2517 2400mg in people with Safety After Oral Intake, run by MDI Therapeutics, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety After Oral Intake
- What is being tested?
- MDI-2517 800mg, MDI-2517 1600mg and MDI-2517 2400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to 25 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable to understand the study procedures and providing signed informed consent as described Section 8.2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Healthy male and female participants 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Body weight of a minimum 50 kg for men and 45 kg for women and body mass index (BMI) within the range of 18.5 to 32 kg/m2
- Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants should be of nonchildbearing potential (postmenopausal i.e., spontaneous amenorrhea for at least 12 months prior to dosing with confirmatory follicle-stimulating hormone [FSH] > 40 mIU/mL, or premenopausal and surgically sterilized), or of childbearing potential who agree to take highly effective contraceptive measures throughout the trial (see Section 11.15 for highly effective contraceptive guidance). Sexually active female participants of childbearing potential with non-sterile male partners, and sexually active non-surgically sterile male participants with female partners of childbearing potential will be required to use highly effective double contraceptive method. Women of childbearing potential and those with less than 24 weeks from menopause must undergo a urine pregnancy test at screening and result must be negative.
- Ability to refrain from consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices from 7 days before participants check into the clinical site until collection of the final PK sample for each participant.
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- Ability to abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, black/green tea, cola drinks, and chocolate) or energy drinks for 48 hours before participants check into the clinical site until after collection of the final PK and/or PD sample.
- Ability to abstain from alcohol for 24 hours before admission to the clinical site until after collection of the final PK and/or PD sample.
- Ability to swallow multiple tablets within a 10 minute window.
Who cannot join
- Major medical illness or unstable medical condition within 6 months of screening that in the opinion of the investigator may interfere with the participant's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data that would prevent completion of study procedures or assessments.
- Any clinically significant abnormal finding at Screening during the physical examination or a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Chronic or ongoing active infectious disease requiring systemic treatment including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, and tuberculosis.
- Any acute infections within 14 days of screening.
- Live attenuated vaccines received within 1 month of screening. Other vaccines, including coronavirus 2019 (COVID-19) vaccine, within 14 days prior to Screening.
- Participants known or suspected of not being able to comply with this study protocol (eg, due to alcoholism, drug dependency or psychological disorder)
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- Laboratory values as follows:
- Any clinically significant lab abnormalities
- AST or ALT; > the upper limit of normal (ULN)
- Total bilirubin > 1.5 times ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%)
- Platelet counts < 150 × 109/L or > 450 × 109/L
- Hemoglobin outside of normal limits
- Coagulation tests (prothrombin time, partial thromboplastin time) outside of normal limits
- Screening corrected QT interval (QTc) > 450 milliseconds for males and > 470 ms for females. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine read or manually overread.
- Screening estimated glomerular filtration rate (eGFR) using 2021 CKD-EPI method <90 mL/min/1.73m2
- Positive serology test results for Hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening. Positive evaluation for COVID-19 infection.
- History of significant allergic reactions (eg, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
- Use of prescription or nonprescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication through the final study visit, unless in the opinion of the investigator and Medical Monitor the medication will not interfere with the study procedures or compromise participant safety with the exception of oral contraception or the occasional use of acetaminophen (up to 2 g daily). Use of monoamine oxidase inhibitors and St. John's Wort within 30 days of dosing.
- Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening through the final study visit.
- Use of tobacco products or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, inhalers or vapes) from 3 months before screening until final follow-up visit. Use of cigarettes 3 months before screening until final visit.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%) through the final study visit.
- History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening through the final study visit.
- History of hypersensitivity to platelet concentrates or human plasma proteins.
- Any type of known platelet function disorder.
- Individuals with increased risk of thrombotic events (eg, history of pulmonary embolism or thrombosis).
- Any blood product donation given or received within 3 weeks of screening or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration. Previously received MDI-2517 study drug or placebo in this study.
- Positive pregnancy test or lactating female participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured.
Read the detailed description
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured. Healthy participants will be monitored for adverse events, laboratory test changes, changes in vital signs, electrocardiogram and the plasma drug levels will be measured. The amount of the drug and its metabolites in urine and blood will be measured. Blood and urine will be used to evaluate the effects of MDI-2517.
- Conditions
- Safety After Oral Intake
- Being tested
- MDI-2517 800mg, Placebo, MDI-2517 1600mg, MDI-2517 2400mg, MDI-2517 3600mg
- Keywords
- single ascending dose, multiple ascending dose, safety, pharmacokinetics, pharmacodynamics, MDI-2517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDI-2517 800mgDrug
800mg MDI-2517 will be administered
PlaceboOther
Matching Placebo
MDI-2517 1600mgDrug
MDI-2517 1600mg will be adminstered
MDI-2517 2400mgDrug
MDI-2517 2400mg will be administered
MDI-2517 3600mgDrug
MDI-2517 3600mg will be administered
| Study group | Role | What they receive |
|---|---|---|
| SAD 1 | Active comparator | SAD cohort 1 will receive a single oral dose of 2400 mg of MDI-2517 or matching placebo Receives: Other: Placebo; Drug: MDI-2517 2400mg |
| SAD 2 | Active comparator | SAD cohort 2 will receive a single oral dose up to 3600 mg of MDI-2517 or matching placebo. Receives: Other: Placebo; Drug: MDI-2517 3600mg |
| MAD 1 | Active comparator | MAD cohort 1 will receive a total daily dose of 800 mg of MDI-2517 or matching placebo administered either once daily (QD) or twice daily (BID). Receives: Drug: MDI-2517 800mg; Other: Placebo |
| MAD 2 | Active comparator | MAD cohort 2 will receive a total daily dose of up to 1600 mg of MDI-2517 or matching placebo administered either QD or BID. Receives: Other: Placebo; Drug: MDI-2517 1600mg |
| MAD 3 | Active comparator | MAD cohort 3 will receive a total daily dose of up to 2400 mg of MDI-2517 or matching placebo administered either QD or BID. Receives: Other: Placebo; Drug: MDI-2517 2400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants
Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants.
This outcome will be measured using:
the number of participants with adverse events (AEs), with abnormal laboratory tests results (chemistry, hematology, coagulation), abnormal vital signs and changes in electrocardiogram"
- The type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
- The type, incidence, and severity of laboratory abnormalities and changes (chemistry, hematology, coagulation)
- Changes in vital signs, and changes in electrocardiogram (ECG QT prolongation) at specified timepoints
Measured: SAD cohorts are up to 34 days - up to 28 days for screening, 1 day of dosing (for SAD cohorts) and 6 days of monitoring. MAD cohorts are up to 40 days - up to 28 days for screening. 7 days of dosing (for MAD cohorts) 12 days of monitoring.
Secondary outcomes (2)
Evaluate the plasma pharmacokinetic (PK) profile of MDI-2517 following ascending single oral doses of MDI2517 in healthy participants
Evaluate the plasma pharmacokinetic (PK) profile of MDI-2517 following ascending single oral doses of MDI2517 in healthy participants. This outcome - the PK profile of MDI-2517- will be measured by analyzing blood samples measuring: Cmax; tmax; AUC0-24; AUC0-t; AUC0-inf; t½; λz; CL/F; Vz/F; and linearity factor)
Measured: SAD cohorts are up to 34 days- Screening up to 28 days. 1 day of dosing (for SAD cohorts) and 6 days of monitoring.
Evaluate the plasma PK profile of MDI-2517 following ascending multiple oral doses of MDI-2517 in healthy participants
Evaluate the plasma PK profile of MDI-2517 following ascending multiple oral doses of MDI-2517 in healthy participants. This outcome - the PK profile of MDI-2517- will be measured by analyzing blood samples- and will be measured using: Cmax; Cmin; tmax; AUC0-24; AUC0-t; AUC0-inf (Day 1 only); t½; λz; CL/F; Vz/F; linearity factor; and accumulation index ratios for Cmax and AUCs.
Measured: MAD cohorts are up to 40 days. Screening up to 28 days. dosing on days 1 to 7 (for MAD cohorts) and 12 days of monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start4 Nov 2025
- Primary completion16 Dec 2025
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety After Oral IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDI Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wyatt, MD, Principal investigator, MDI Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220889
- Sponsor's protocol ID
- MDI-2517-01-002
- Status last verified
- May 2026
- First submitted
- 19 Oct 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07220889
- Acronym / sponsor ID
- MDI-2517-01-002
- Conditions
- Safety After Oral Intake
- Keywords
- single ascending dose, multiple ascending dose, safety, pharmacokinetics, pharmacodynamics, MDI-2517
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- MDI Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured.
Detailed description
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants. Healthy participants will take single or multiple doses of drug and the safety and drug levels will be measured. Healthy participants will be monitored for adverse events, laboratory test changes, changes in vital signs, electrocardiogram and the plasma drug levels will be measured. The amount of the drug and its metabolites in urine and blood will be measured. Blood and urine will be used to evaluate the effects of MDI-2517.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SAD 1 | Active comparator | Other: Placebo, Drug: MDI-2517 2400mgSAD cohort 1 will receive a single oral dose of 2400 mg of MDI-2517 or matching placebo |
| SAD 2 | Active comparator | Other: Placebo, Drug: MDI-2517 3600mgSAD cohort 2 will receive a single oral dose up to 3600 mg of MDI-2517 or matching placebo. |
| MAD 1 | Active comparator | Drug: MDI-2517 800mg, Other: PlaceboMAD cohort 1 will receive a total daily dose of 800 mg of MDI-2517 or matching placebo administered either once daily (QD) or twice daily (BID). |
| MAD 2 | Active comparator | Other: Placebo, Drug: MDI-2517 1600mgMAD cohort 2 will receive a total daily dose of up to 1600 mg of MDI-2517 or matching placebo administered either QD or BID. |
| MAD 3 | Active comparator | Other: Placebo, Drug: MDI-2517 2400mgMAD cohort 3 will receive a total daily dose of up to 2400 mg of MDI-2517 or matching placebo administered either QD or BID. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Capable to understand the study procedures and providing signed informed consent as described Section 8.2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Healthy male and female participants 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Body weight of a minimum 50 kg for men and 45 kg for women and body mass index (BMI) within the range of 18.5 to 32 kg/m2
- Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants should be of nonchildbearing potential (postmenopausal i.e., spontaneous amenorrhea for at least 12 months prior to dosing with confirmatory follicle-stimulating hormone [FSH] > 40 mIU/mL, or premenopausal and surgically sterilized), or of childbearing potential who agree to take highly effective contraceptive measures throughout the trial (see Section 11.15 for highly effective contraceptive guidance). Sexually active female participants of childbearing potential with non-sterile male partners, and sexually active non-surgically sterile male participants with female partners of childbearing potential will be required to use highly effective double contraceptive method. Women of childbearing potential and those with less than 24 weeks from menopause must undergo a urine pregnancy test at screening and result must be negative.
Key exclusion criteria (28 listed)
- Major medical illness or unstable medical condition within 6 months of screening that in the opinion of the investigator may interfere with the participant's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data that would prevent completion of study procedures or assessments.
- Any clinically significant abnormal finding at Screening during the physical examination or a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Chronic or ongoing active infectious disease requiring systemic treatment including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, and tuberculosis.
- Any acute infections within 14 days of screening.
- Live attenuated vaccines received within 1 month of screening. Other vaccines, including coronavirus 2019 (COVID-19) vaccine, within 14 days prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDI-2517 800mg800mg MDI-2517 will be administered | Drug | MAD 1 |
| PlaceboMatching Placebo | Other | MAD 1, MAD 2, MAD 3, SAD 1, SAD 2 |
| MDI-2517 1600mgMDI-2517 1600mg will be adminstered | Drug | MAD 2 |
| MDI-2517 2400mgMDI-2517 2400mg will be administered | Drug | MAD 3, SAD 1 |
| MDI-2517 3600mgMDI-2517 3600mg will be administered | Drug | SAD 2 |
Primary outcome
Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants
Time frame: SAD cohorts are up to 34 days - up to 28 days for screening, 1 day of dosing (for SAD cohorts) and 6 days of monitoring. MAD cohorts are up to 40 days - up to 28 days for screening. 7 days of dosing (for MAD cohorts) 12 days of monitoring.
Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants. This outcome will be measured using: the number of participants with adverse events (AEs), with abnormal laboratory tests results (chemistry, hematology, coagulation), abnormal vital signs and changes in electrocardiogram" * The type, incidence, severity, seriousness, and relatedness of adverse events (AEs) * The type, incidence, and severity of laboratory abnormalities and changes (chemistry, hematology, coagulation) * Changes in vital signs, and changes in electrocardiogram (ECG QT prolongation) at specified timepoints
2 secondary outcomes
Evaluate the plasma pharmacokinetic (PK) profile of MDI-2517 following ascending single oral doses of MDI2517 in healthy participants
Time frame: SAD cohorts are up to 34 days- Screening up to 28 days. 1 day of dosing (for SAD cohorts) and 6 days of monitoring.
Evaluate the plasma PK profile of MDI-2517 following ascending multiple oral doses of MDI-2517 in healthy participants
Time frame: MAD cohorts are up to 40 days. Screening up to 28 days. dosing on days 1 to 7 (for MAD cohorts) and 12 days of monitoring.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wyatt, MD principal investigator
MDI Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDI-2517 800mg, MDI-2517 1600mg and MDI-2517 2400mg in people with Safety After Oral Intake, run by MDI Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of single and multiple ascending oral doses of MDI-2517 in healthy participants (time frame: SAD cohorts are up to 34 days - up to 28 days for screening, 1 day of dosing (for SAD cohorts) and 6 days of monitoring. MAD cohorts are up to 40 days - up to 28 days for screening. 7 days of dosing (for MAD cohorts) 12 days of monitoring.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.